A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism

A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism - A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011356

Enrollment

Registered

2013-08-05

Start date

2013-08-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital hyperinsulinism

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with diazoxide-unresponsive congenital hyperinsulinism treated by subcutaneous octreotide injection. (2) Patients whose guardians gave an informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Secondary

Measure	Time frame
(1) Reduction in glucose infusion rate at other time points. (2) Neurological outcome at 1 year after initiation of the treatment. Normal as defined by the developmental quotient (DQ) > 70, delay as defined by DQ < 69. (3) Safety profile as assessed by body measurements, adverse events, laboratory tests, and abdominal ultrasound.	—

Primary

Measure	Time frame
Reduction in glucose infusion rate to keep euglycaemia at 4 weeks after initiation of the treatment. Effective as defined by the reduction of glucose infusion to less than 8.64 g/kg/d. Remarkably effective as defined by the cessation of glucose infusion.	—

Countries

Japan

Contacts

Public ContactTohru Yorifuji

Osaka City General Hospital Clinical Research Center

scorch-registry@med.osakacity-hp.or.jp06-6929-1221

Outcome results